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November 17, 2004
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Herbal supplements: How they're labeled and regulated

By Mayo Clinic staff

Surf the Internet or walk into any natural foods store, pharmacy, chain discount store or grocery store, and you'll find them — herbal remedies: St. John's wort, echinacea, ginkgo, saw palmetto and hundreds of others. Each claims to provide a gentle, natural means of enhancing your health.

Clinical studies have proved that some herbal supplements, such as black cohosh, are safe and effective — when used correctly — while the usefulness of many others still hasn't been established. Some herbs that have been associated with harmful side effects remain on the market. But research has weeded out other dangerous herbs. In late December 2003, for instance, the Food and Drug Administration announced the ban of ephedra from the marketplace because of health concerns.

 
What are herbal supplements?

The Food and Drug Administration (FDA), which oversees the safety of food and drugs sold in the United States, considers herbal, vitamin and mineral supplements all to be dietary supplements.

Herbal medicines are derived from natural sources. Many prescription and over-the-counter medications are, too. Each of these should be treated with caution. If you do choose herbal supplements, be sure to talk to your doctor first. Your doctor can tell you whether:

  • Any herbs you take or are interested in taking have potentially dangerous side effects
  • Specific herbal medicines are appropriate for you given your overall health status
  • Any herbal medicines can interact with other medications you currently use
  • You could achieve the same results you desire from herbal supplements by changing your lifestyle — for example, your diet or exercise program

Your doctor may be cautious about endorsing or embracing most herbal supplements. This is most often because relatively few controlled studies have been done on herbal supplements. However, a growing number of doctors are working to better understand herbal therapies so that they can help you make informed decisions about your health care.


 
A word of caution: Limited FDA regulation

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA). This act limited the FDA's control over products labeled a "dietary supplement." The DSHEA states that manufacturers don't have to prove the safety or efficacy of a product before they put it on the market. With this act, Congress acknowledged that consumers believe supplements provide health benefits and that they want greater responsibility for deciding if herbs are helpful to them.

As a result, herbal products and supplements aren't subject to the same rigorous standards as are prescription drugs or those sold over the counter. Herbal supplements can be marketed with limited proof of effectiveness or safety. Vendors can make health claims about products based on their own review and interpretation of studies without FDA authorization. However, the FDA can pull a product off the market if it's proved dangerous.

 
Seals of approval: No guarantee

In the absence of federal certification of the safety of herbal medicines, a few private sector groups have made an effort to regulate these products. These groups include the U.S. Pharmacopoeia, ConsumerLab.com, Good Housekeeping and NSF International. Although each group takes a slightly different approach, the goal of each is to certify that herbal medicines available to the public meet these standards:

  • Does the product meet recognized standards of quality?
  • Does the label accurately reflect what's in the product?
  • Is the product reasonably free of contaminants such as heavy metals or pesticides?
  • Was the product produced and packaged under clean and safe conditions?

These programs aren't required to report herbs that fail to meet these standards, only those that pass. And they typically don't guarantee that a product works as it's purported to or that it's safe to use.

Only the Good Housekeeping program requires a product to prove that it's safe and effective. To obtain this certification, a manufacturer must submit research-based evidence that the product does what it claims to do and that it does so without harming the consumer.

 
Labels: What's required?

Despite this general lack of oversight, you can expect certain information to be included on the labels of all herbal supplements. As part of the DSHEA, dietary supplements must have an information panel that includes:

  • Its name, for example, St. John's wort.
  • Net quantity of contents, for example, 60 capsules.
  • Ingredients and amounts.
  • Disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."
  • Supplement Facts panel, which includes serving size, amount and active ingredient.
  • Other ingredients, such as herbs and amino acids, for which no daily values have been established.
  • Name and address of manufacturer, packer or distributor.

Manufacturers typically refer to herbal products by their common name and the part of the plant used to make the supplement, such as root, stem or leaf. If the common name isn't listed in the American Herbal Products Association's Herbs of Commerce, the Latin name is used.

As doctors and researchers continue to explore the safety and effectiveness of herbal supplements, more is learned about both their promises and their pitfalls. At the same time, legislators at the national level continue to press for effective laws to protect consumers from potentially harmful herbal supplements. In the meantime, your own scrutiny and curiosity are your best protection. Read labels closely and talk with your doctor or pharmacist about any herbal supplements you're taking or considering taking.

Related Information

Additional Resources

December 31, 2003

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